Study identifier:D3690C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Double-blind, Randomised, Multicentre, Placebo-controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc interval of Repeated and Escalating Doses of AZD3480 during 6 Days, using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.
Healthy
Phase 1
Yes
AZD3480, Moxifloxacin, PLACEBO
Male
75
Interventional
20 Years - 60 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Prevention
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: 1 Escalating doses of AZD3480 during 6 days | Drug: AZD3480 Capsule, oral, single dose, 6 days Other Name: TC-1734-226 |
Experimental: 2 Repeated doses of AZD3480 during 6 days | Drug: AZD3480 Capsule, oral, single dose, 6 days Other Name: TC-1734-226 |
Placebo Comparator: 3 Placebo during 6 days | Drug: PLACEBO Capsule, oral, single dose |
Active Comparator: 4 Placebo during 5 days, active day 6 | Drug: Moxifloxacin Capsule(encapsulated), oral, single dose Other Name: Moxifloxacin |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.